FDA 510(k)

2 Face / Face Evolution

K 號：K171821 · 2018-04-26

決定日期2018-04-26

產品代碼NFO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

2 Face / Face Evolution is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click. It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K171821. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 2 Face / Face Evolution?

2 Face / Face Evolution is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is Heat IN A Click. The 510(k) number is K171821.

When did 2 Face / Face Evolution receive FDA 510(k) clearance?

2 Face / Face Evolution received FDA 510(k) clearance on 2018-04-26, under 510(k) number K171821.

Who is the listed applicant for 2 Face / Face Evolution?

The FDA 510(k) record lists Heat IN A Click as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2 Face / Face Evolution?

The FDA product code for 2 Face / Face Evolution is NFO.

其他以 Heat IN A Click 為申請人之記錄

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